Federal officials have announced a recall for a specific model of heart catheter made by Medtronic PLC that regulators said is responsible for one death and two injuries.
The action Tuesday involves 142 Rashkind balloon septostomy catheters that were distributed in the United States from May 2018 to August 2020.
"Quality issues ... may lead to the device breaking, separating or failing during use," according to the U.S. Food and Drug Administration (FDA).
"If this occurs," the recall notice continued, "use of the affected product may cause serious adverse health consequences such as damage to blood vessels — vascular injury — and death."
The FDA has identified this move as a Class 1 recall, the most serious, given the death and injuries attributed to the device.
The catheters are used to enlarge an existing atrial septal defect as a treatment option for patients with cyanotic congenital heart defects.
Along with recalling the catheters already on the market, Medtronic has stopped making and distributing this particular catheter due to unspecified reasons "unrelated to this recall," the FDA noted.
On Sept. 9, Medtronic, which is based in Dublin, Ireland, and run from offices in the Twin Cities, sent an urgent letter to all affected customers directing them to return the catheters to Medtronic.
Health care professionals and consumers can report adverse reactions or quality problems online to the FDA's MedWatch safety information and adverse event reporting program.
Paul Walsh • 612-673-4482
